Coronal Mode Ultrasound Guided Hemodialysis Cannulation: A Pilot Randomized Comparison With Standard Cannulation Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Infiltration Due to Dialysis Access Cannulation
研究概览
简要总结
Infiltrations from cannulation difficulties result in significant morbidity including loss of vascular access (VA) loss in hemodialysis (HD). Cannulation is reliant on personnel skill and VA characteristics. Surface marking of VA lacks real-time information and traditional ultrasound (US) devices are large, expensive and require skilled operator expertise. Sonic Window© (Analogic Ultrasound, Peabody, MA) is a coronal mode ultrasound device (CMUD) approved for VA cannulation. Study is a single center randomized, prospective pilot study comparing handheld US-guided cannulation of new arteriovenous fistula (AVF) to standard cannulation practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End-stage renal disease with new arteriovenous fistula being started for cannulation
排除标准
- •End-stage renal disease with grafts
研究组 & 干预措施
Standard cannulation
The standard cannulation protocol of the center was defined as using 17 gauge needles for the first 3 dialysis sessions, followed by 16 gauge for the next 3, and finally 15 gauge for subsequent sessions.
Ultrasound guided cannulation
The study protocol involved similar up titration of needle size over a 3-week period, except that a pre-cannulation evaluation of the fistula was performed using the Sonic Window ultrasound device. The device was used to evaluate and identify the optimal site of cannulation (image 1). Depending upon the cannulator's preference, real-time guidance could be employed during cannulation (image 2, 3). The cannulations were performed by 4 selected personnel trained in device use and successfully completed a competency evaluation on simulator models and a mature dialysis fistula.
干预措施: Sonic Window ultrasound device (Device)
结局指标
主要结局
Infiltration Due to Dialysis Access Cannulation
时间窗: 3 weeks from use of fistula
Infiltration is the extravasation of blood from fistula due to problems with needle insertion into fistula for dialysis.
次要结局
- Patient Pain Scale(3 weeks from use of fistula)
研究者
Lalathaksha Kumbar
Senior staff Physician
Henry Ford Health System